A series of denials and a failure to formally investigate allegations of misconduct in Andrew Wakefield's MMR research meant the public was misled about the credibility of the paper for six years.
Dr Fiona Godlee, BMJ Editor in Chief, says the UK has consistently failed to take research misconduct seriously. She calls on the UK government to establish mandatory oversight of clinical research integrity within the NHS, as happens for publicly funded research in the USA.
"This case reveals major flaws in pre and post-publication peer review," she says. "Allegations of research misconduct must be independently investigated in the public interest. But it's still too easy for institutions to avoid external scrutiny, and editors can fail to adequately distance themselves from work they have published and then defended."
In the third and final part of a special BMJ series, “Secrets of the MMR scare”, investigative journalist Brian Deer reveals how the medical establishment closed ranks to protect Wakefield after he raised concerns with the Lancet in 2004.
Deer’s allegations included possible research fraud, unethical treatment of vulnerable children, and Wakefield’s conflict of interest through his involvement with a lawsuit against vaccine manufacturers.
Deer thought the editor, Richard Horton, would say that an investigation was needed. Instead he reports that “within 48 hours, and working with the paper’s three senior authors, the journal was to publish 5000 words of denials, in statements, unretracted to this day.”
The statements said that an investigation was undertaken by the Royal Free Hospital that “cleared Wakefield of wrongdoing.”
But documents, emails, and replies obtained under the Freedom of Information Act reveal no formal investigation. “What emerges is merely a scramble to discredit my claims during the 48 hours after I disclosed the information,” writes Deer. In short, “the accused were investigating themselves.”
It took a further six years for the General Medical Council (GMC) to prove Deer’s allegations, and for the Lancet paper to be retracted. During this time, public alarm over MMR continued, measles outbreaks occurred, and two UK children died from the disease.
“Were it not for the GMC case, which cost a rumoured £6m (€7m; $9m), the fraud by which Wakefield concocted fear of MMR would forever have been denied and covered up,” argues Deer. The Royal Free Hospital and Medical School have since confirmed that they carried out no formal investigation. No doctor was interviewed, and no documents were generated.
In a written response to the BMJ last week, Professor Sir John Tooke, Vice-Provost at Univesity College London said: "UCL takes any allegation of research misconduct very seriously, and we will certainly investigate those raised in the BMJ. He added: "We are determined to learn from the mistakes made in relation to this case ... Our objective is to continue refining a structure and processes which provide all reasonable safeguards whilst also facilitating the highest quality research for population benefit."
An accompanying editorial by researchers in Seattle says Deer’s articles reveal the urgent need "to fix a system that failed to protect human subjects and the public from the consequences of fraudulent science."
Brian Deer, Journalist, London, UK
Tel: +44 (0)7795 161 889
Dr Fiona Godlee, Editor in Chief, BMJ, London, UK (via Emma Dickinson, BMJ Group Press Officer)